Consulta CRT-D, Maximo II CRT-D, Protecta XT CRT-D and Protecta CRT-D
FDA premarket approval P010031/S658 · decided 2019-03-05
Approval details
- PMA number
- P010031
- Supplement
- S658
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Consulta CRT-D, Maximo II CRT-D, Protecta XT CRT-D and Protecta CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2019-01-30
- Decision date
- 2019-03-05
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for labeling updates to the clinical study summary for the post approval study.
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